Michael T. Osterholm
On Feb. 14, the FDA released a statement about its response to the ongoing COVID-19 outbreak, noting that it is “keenly aware” that the outbreak will, in all likelihood, affect the medical supply chain. According to the release, the FDA has deployed additional resources to help determine possible weaknesses in the U.S. medical product sector caused by the outbreak. The agency has also been proactive in trying to identify potential disruptions and shortages, according to the release, instead of “waiting for drug and device manufacturers to report shortages to us.”
Healio spoke with Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, about what products could be involved in such a shortage, as well as the effect — and disruptions — the outbreak will likely have on the medical supply chain, including lifesaving medicines. – by Caitlyn Stulpin
Q: How can a large-scale outbreak or pandemic disrupt the supply of essential medications?
A: First of all, we’re already in a situation where critical lifesaving drugs that we need in this country every day are in short supply. Part of it has to do with generic drugs — they’re more of a commodity product that does not demand a high return on investment for those companies that make them. Second, many of these drugs are made outside of the United States, which means that we don’t really have any control over the actual manufacturing or shipment of these drugs. Because of that, we are in a position where we will – even during a routine day — see a shortage of the 153 lifesaving drugs that we’ve identified that we need every day to keep people alive; there was a shortage of 63 of these drugs before this outbreak even began. Now, we have a situation where the supply chain in China, where these drugs are made, is severely compromised because people aren’t working and transportation isn’t operating. All of that will burden these very stressed supply chains even more. We’re going to see shortages around the world.
On Feb. 14, the FDA released a statement about their response to the ongoing COVID-19 outbreak, noting that they were “keenly aware” that the outbreak will, in all likelihood, affect the medical supply chain.
Q: Are there indications that the coronavirus outbreak in China is having a negative effect on the medication supply chain?
A: There are no such indications yet, but that’s only because the supply chains are long enough — meaning that they produce at least 2 to 3 months’ worth of product. Think of this like a hose: When you shut off the water, it takes a second to stop water from coming out of the other end. Our concern is what happens if, as we see this outbreak continue to unfold in China, the actual supply chain shuts down, and 2 to 3 months from now, we see very few drug in that supply chain on top of what is already a bit of a shortage?
Q: How prepared are we for such disruptions?
A: We’re not. We’re just not. Part of the challenge we have right now is that there are no other alternatives for getting these drugs. It’s not like they’re made in other countries. We are really in a bad way if we continue to see the supply chains challenged. In the U.S., it will be a very severe problem. These 153 drugs account for keeping many, many people alive in this country every day and, without them, it’s going to be a real challenge and we don’t have any alternatives.
Q: What needs to be done to mitigate these concerns?
A: We can’t solve this in the short term. We need to realize that this is a long-term situation and we’re going to have to ask ourselves if we want to put ourselves in a hostage situation with other countries and with microbes, one that we are already finding ourselves in. If that’s not the case, we’re going to have to think of how we can develop capacity here or in other parts of the world. Are we going to start manufacturing these drugs here? Are we going to have redundancies somewhere in the world that would allow us to get those kinds of drugs? That’s going to be a major question that society is going to have to ask itself.
Disclosures: Osterholm reports no relevant financial disclosures.